A Study of Dimdazenil in Patients With Parkinson's Disease and Insomnia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Soochow University
About this trial
This study will use sleep parameters measured by polysomnography (PSG) as the primary means to evaluate the efficacy and safety of dimdazenil, a GABAA receptor partial agonist, in treating insomnia in Parkinson's disease patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide written informed consent voluntarily after full comprehension of the study.
Be aged ≥18 years, male or female.
Meet the diagnostic criteria for Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), with a modified Hoehn-Yahr stage ≤3.
Have insomnia symptoms [reduced total sleep time (<6.5 h) and/or sleep-onset latency >30 min, and/or ≥2 nocturnal awakenings, early-morning awakening, or poor sleep quality], occurring at least three times per week, accompanied by daytime dysfunction or daytime distress, with adequate opportunity for sleep yet difficulty initiating or maintaining sleep, and that cannot be fully explained by another sleep-wake disorder; and have satisfactory control of Parkinson's disease motor symptoms [MDS-UPDRS Part III (ON state) score ≤30].
Disqualifiers
Have Parkinson-plus syndromes, secondary parkinsonism, or other non-idiopathic Parkinson's disease.
Have used benzodiazepine sedative-hypnotics within 7 days prior to enrollment.
Have other significant comorbidities, such as malignant tumors, or clinically significant impairment of cardiac, hepatic, or renal function.
Have severe obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), respiratory insufficiency, or myasthenia gravis.
Trial population
Parkinson's disease with insomnia，aged ≥18 years, male or female
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Parkinson's disease patients with insomnia, aged ≥18 years, male or female
Trial outcomes
Primary outcomes
1
Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14 of dimdazenil treatment
Total sleep time (TST) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).
Time frame
Baseline, Night 14Secondary outcomes
1
Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 1 of dimdazenil treatment
Total sleep time (TST) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).
Time frame
baseline, Night 12
Change from baseline in Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination score after 14 days of dimdazenil treatment
Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) is the motor examination section of the MDS-UPDRS, used to assess the severity of motor symptoms in patients with Parkinson's disease. The MDS-UPDRS-III comprises 27 items across 14 categories, including facial expression, tremor, rigidity, bradykinesia, postural instability, and gait examination. Each item is scored on a 5-point Likert scale (ranging from 0 to 4), with a total score range of 0 to 108. Higher scores indicate more severe motor symptoms.
Time frame
baseline, Day 143
Change from baseline in latency to persistent sleep (LPS) measured by polysomnography (PSG)
Latency to persistent sleep (LPS) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG), defined as the time from the start of PSG recording to the onset of non-rapid eye movement (NREM) sleep stage 1。
Time frame
baseline, Night 1，Night 144
Change from baseline in wake after sleep onset (WASO) measured by polysomnography (PSG)
Wake after sleep onset（WASO） is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG)。Polysomnography (PSG) is a medical device that comprehensively evaluates sleep quality by simultaneously recording more than 10 physiological parameters, including electroencephalography (EEG)。PSG is regarded as the "gold standard" for the diagnosis of sleep disorders.
Time frame
baseline, Night 1，Night 14Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital of Soochow University
Lead sponsor
The Fourth Affiliated Hospital of Soochow University
Collaborator
Changshu Hospital of Traditional Chinese Medicine
Collaborator
The Second Affiliated Hospital of Jiaxing University
Collaborator
Source ClinicalTrials.gov
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